PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

Early Phase 1

• Conditions: Obesity
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02254395
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Subject is aged 18 to 65.
2. Body Mass Index [BMI] >40 kg/m2.

Exclusion Criteria

1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery
2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
3. Participate in other clinical trial;
4. Has a life expectancy of < 1 year.
5. The investigator and/or enrollment review committee, would preclude participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Deep Brain Stimulation	Sham Stimulation: Stimulation is off.
Deep Brain Stimulation	Deep Brain Stimulation	Stimulation is on.

Primary Outcome Measures

Name	Time	Method
Body Weight	12 month	Body weight will be recorded at every follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	12 month
Food Intake	12 month